Duloxetine delayed-release capsules

What is this medicine?

DULOXETINE (doo LOX e teen) is used to treat depression, anxiety, and different types of chronic pain.

How should I use this medicine?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. Do not crush, cut or chew some capsules of this medicine. Some capsules may be opened and sprinkled on applesauce. Check with your doctor or pharmacist if you are not sure. You can take this medicine with or without food. Take your medicine at regular intervals. Do not take your medicine more often than directed. Do not stop taking this medicine suddenly except upon the advice of your doctor. Stopping this medicine too quickly may cause serious side effects or your condition may worsen.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for children as young as 7 years of age for selected conditions, precautions do apply.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

Where should I keep my medicine?

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

bipolar disorder

glaucoma

high blood pressure

kidney disease

liver disease

seizures

suicidal thoughts, plans or attempt; a previous suicide attempt by you or a family member

take medicines that treat or prevent blood clots

taken medicines called MAOIs like Carbex, Eldepryl, Marplan, Nardil, and Parnate within 14 days

trouble passing urine

an unusual reaction to duloxetine, other medicines, foods, dyes, or preservatives

pregnant or trying to get pregnant

breast-feeding

What should I watch for while using this medicine?

Tell your doctor if your symptoms do not get better or if they get worse. Visit your doctor or healthcare provider for regular checks on your progress. Because it may take several weeks to see the full effects of this medicine, it is important to continue your treatment as prescribed by your doctor.

This medicine may cause serious skin reactions. They can happen weeks to months after starting the medicine. Contact your healthcare provider right away if you notice fevers or flu-like symptoms with a rash. The rash may be red or purple and then turn into blisters or peeling of the skin. Or, you might notice a red rash with swelling of the face, lips, or lymph nodes in your neck or under your arms.

Patients and their families should watch out for new or worsening thoughts of suicide or depression. Also watch out for sudden changes in feelings such as feeling anxious, agitated, panicky, irritable, hostile, aggressive, impulsive, severely restless, overly excited and hyperactive, or not being able to sleep. If this happens, especially at the beginning of treatment or after a change in dose, call your healthcare provider.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells. Alcohol may interfere with the effect of this medicine. Avoid alcoholic drinks.

This medicine can cause an increase in blood pressure. This medicine can also cause a sudden drop in your blood pressure, which may make you feel faint and increase the chance of a fall. These effects are most common when you first start the medicine or when the dose is increased, or during use of other medicines that can cause a sudden drop in blood pressure. Check with your doctor for instructions on monitoring your blood pressure while taking this medicine.

Your mouth may get dry. Chewing sugarless gum or sucking hard candy, and drinking plenty of water, may help. Contact your doctor if the problem does not go away or is severe.